To relieve mild to moderate pain and to reduce fever in many conditions including headache, toothache, teething, feverishness, colds, influenza, and following vaccination.

Do not give:

•       If your child is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can include a rash, itching or shortness of breath.

•       If your child has a liver disorder.

•       If your child has an intolerance to some sugars, unless your doctor tells you to (this medicine contains sorbitol)

Take special care with Fevadol Syrup

Talk to your pharmacist or doctor before taking Paracetamol if you have:

•       The baby was born prematurely and is under 3 months.

•       If your child has liver or kidney problems

Liver warning: “This product contains paracetamol. Maximum daily dose is shown in table 1(section 3: how to give this medicine), Severe or possibly fatal liver damage may occur if you take more than the recommended dose in 24 hours or with other drugs containing paracetamol.”

Other medicines and Paracetamol:

You must not take any other medicines that contain paracetamol while you are taking this medicine.

Tell your doctor if you are taking any of these medicines:

·       barbiturates (sleeping tablets)

·       tricyclic antidepressants (such as amitriptyline)

·       colestyramine (used to treat high cholesterol)

·       warfarin (used to thin the blood and prevent clotting)

·       zidovudine (used in HIV infections and AIDS)

·       domperidone and metoclopramide (used to treat nausea and vomiting)

·       anticonvulsants (medicines used to treat epilepsy or fits)

·       oral contraceptives “the pill”.

Please inform your doctor or pharmacist if you are taking:

·       Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (high anion gap metabolic acidosis) that must have urgent treatment and which may occur particularly in case of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

·       Phenytoin may reduce the analgesic and antipyretic effects of paracetamol and may increase risk of hepatotoxicity.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Other important information

Information for people with diabetes: If the child has a known intolerance to some sugars, contact your doctor before use as this product contains sorbitol.

Pregnancy and breastfeeding:

If you are pregnant, planning to become pregnant or are breast-feeding, talk to your doctor or

pharmacist before taking this medicine.

Driving and using machines:

This medicine should not affect your ability to drive or use machines.

Take this medicine as your doctor or pharmacist has told you. Look on the label and ask your

doctor or pharmacist if you are not sure.

The dose should be weight-related dosing in the label instructions. If the weight of the child is unknown, age-related dosing is provided (See table 1 below).

Taking this medicine

Check the tables below to see how much of the medicine to use

•       This medicine contains 160mg of paracetamol in one 5ml spoonful (32 mg/mL).

•       Take this medicine by mouth only.

•       Never give more medicine than shown in table.

•       It is important to shake the bottle for at least 10 seconds before use.

•       Always use the spoon supplied with the pack. Do not overfill the spoon.

•       Do not give this medicine with any other paracetamol-containing product.

•       Seek medical advice before giving to the preterm neonate or term neonates <10 days.

•       Repeat 4 – 6 hourly up to 5 times per day if required.

•       No more than 5 doses in any 24-hour period, unless directed by physician.

•       Should not be used for more than 5 days for children ≥2 years and 3 days for infants (<2 years) except on medical advice.

If you take more paracetamol than you should (overdose):

•       Immediate medical advice should be sought in the event of an overdose, even if your child seems well, because of the risk of delayed, serious liver damage. Phone your doctor or go to your nearest accident and emergency department straight away.

•       There may be no symptoms during the first 24 hours although paleness, nausea (feeling sick), vomiting (being sick) and abdominal pain may occur.

If you forget to take this medicine:

Take the next dose when needed. Do not take a double dose to make up for a forgotten dose.

Like all medicines, paracetamol can cause side effects, although not everybody gets them.

The side effects below may sometimes happen.

If you have an allergic reaction to this medicine, see a doctor straight away.

An allergic reaction may include:

•       skin rash, flaking skin, boils, sore lips and mouth, swelling of the face, fever.

•       sudden wheezing, fluttering or tightness of the chest or collapse.

If you get any of the following side effects, stop taking this medicine and see your doctor as

soon as possible:

•       bruising more easily, sore throat or other signs of infection (these may be signs of a blood disorder).

•       severe pain in the abdomen and back, with fever (high temperature), loss of appetite, nausea and vomiting (these may be signs of pancreas inflammation).

•       very rare cases of serious skin reactions have been reported.

Tell your doctor if you get any of these side effects:

•       Skin rash

If paracetamol is taken for a long time, it may lead to liver and kidney problems but if the right amount is taken over a short period of time there should be no problems.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via The National Pharmacovigilance and Drug Safety Centre (NPC). By reporting side affects you can help provide more information on the safety of this medicine.

Store in the original package. Keep the lid tightly closed.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard to be protected from light.

Do not refrigerate it.

Do not store above 30°C.

This medicine will be expired after 30 days from the first opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.